Dopamine Rhythms in Health and Addiction (NCT02233829) | Clinical Trial Compass
WithdrawnEarly Phase 1
Dopamine Rhythms in Health and Addiction
Stopped: No enrollment, delay with drug availability.
United States0Started 2024-04-23
Plain-language summary
Background:
\- Dopamine is a chemical signal linked to the rewarding effects of drugs. Certain genes make these effects sensitive to the time of day they are taken. Cocaine can affect these genes in the brain. Researchers want to measure brain dopamine at different times of day.
Objectives:
\- To look for changes to a person s biological clock in the function of the dopamine reward system. To test if cocaine disrupts this.
Eligibility:
* Adults age 21-55 with a cocaine use disorder.
* Healthy volunteers age 21-55.
Design:
* Participants will be screened with medical history, physical exam, interview, and blood and urine tests. Their breath will be tested for alcohol and recent smoking.
* Participants will have 3 overnight clinic visits.
* Visit 1: They will have blood and urine collected and a heart test.
* A plastic tube (catheter) will be placed into a vein in each arm by needle.
* Participants will have a PET scan in a donut-shaped machine. They will lie on a bed that slides in and out of it, wearing a cap. A radiotracer (measures dopamine) and a drug (blocks dopamine removal) will be injected via catheter. Vital signs will be measured and blood will be drawn throughout.
* Visit 2: repeats Visit 1, except at night.
* Visit 3, participants will have urine collected.
* They will have MRI scans in a metal cylinder surrounded by a magnetic field. They will lie on a table that slides in and out of it, with a coil over their head.
* Participants may answer questions, take computer or paper tests, and perform simple actions.
* For 1 week, participants will wear a wrist device that measures daily activity.
Who can participate
Age range21 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Between 21 and 55 years of age.
✓. Ability to provide written informed consent.
✓. DSM-IV or DSM-5 diagnosis of a moderate or severe cocaine use disorder established through history and clinical exam.
✓. Non-treatment seeking cocaine users (actively consuming cocaine - last use within one week of study as assessed by self-reports).
✓. Minimum 10 years history of cocaine abuse predominantly via smoking or injection - self-report.
✓. Must consume at least 4 grams of cocaine per week - self-report.
Exclusion criteria
✕. Unwilling or unable to refrain from use within 24 hours of scheduled study procedures: psychoactive medications or medications that may affect study results e.g., antibiotics (must finish course at least 24 hours prior to a scheduled procedure), antidiarrheal preparations, anti-inflammatory drugs \[systemic corticosteroids are exclusionary\], anti-nausea, cough/cold preparations) (self-report, medical history). The following medications are allowable for entry on this study: analgesics (non-narcotic and narcotic for OUD participants); antacids; antiasthma agents that are not systemic corticosteroids; antifungal agents for topical use; antihistamines (non-sedating); H2-Blockers/PPI (proton pump inhibitors); laxatives. The use of antihyperlipidemics and/or diuretics are permitted if they have been taken for at least 1 month before procedure visits and dose has been stabilized as determined by medical history and physical exam. The episodic use of benzodiazepines such as alprazolam ((TM)Xanax), diazepam ((TM)Valium) and lorazepam ((TM)Ativan), will not exclude participants from this study unless they have been taken within the last 24 hours prior to the study.
What they're measuring
1
To determine if there is disruption in circadian rhythms in cocaine use disorder (CUD) as compared to healthy controls.
Timeframe: end of study
Trial details
NCT IDNCT02233829
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
✕. Current or past DSM-IV or DSM-5 diagnosis of a psychiatric disorder (other than cocaine for the cocaine abusers, and nicotine/caffeine for any of the participants) that required hospitalization (any length), or chronic medication management (more than 4 weeks) and that could impact brain function at the time of the study as determined by history and clinical exam.
✕. The following current chronically used medications are exclusionary from the study: stimulant or stimulant-like medications (amphetamine, methylphenidate, modafinil) ; analgesics containing narcotics (for controls only); anorexics (sibuteramine); antianginal agents; antiarrhythmics; antiasthma agents that are systemic corticosteroids; antibiotics; anticholinergics; anticoagulants; anticonvulsants; antidepressants; antidiarrheal preparations; antifungal agents (systemic); antihistamines (sedating); antihypertensives; anti-inflammatory drugs (systemic); antineoplastics; antiobesity; antipsychotics; antivirals (except for treatment of HSV with agents without CNS activity, e.g. acyclovir, ganciclovir, famciclovir, valacyclovir); anxiolytics (benzodiazepine or barbiturates); hormones (exceptions: thyroid hormone replacement, oral contraceptives, and estrogen replacement therapy); insulin; lithium; muscle relaxants; psychotropic drugs not otherwise specified (nos) including herbal products (no drugs with psychomotor effects or with anxiolytics, stimulant, antipsychotic, or sedative properties); sedatives/hypnotics. Note that nicotine and/or caffeine use will not exclude participants and that the use of cocaine will not exclude participants with CUD.
✕. Major medical problems that can permanently impact brain function (e.g., CNS including seizures and psychosis; cardiovascular including hypertension \[BP \> 140/90\] and clinically significant arrhythmias except bradycardia; metabolic, autoimmune, endocrine; +HIV) as determined by history.
✕. Any clinically significant laboratory finding as determined during the screening procedures that could impact brain function or study procedures as evidenced from clinical laboratory results. Since half of the participants in the study will have a diagnosis of cocaine use disorder (CUD), we expect some clinically significant findings that would reflect their recent cocaine use. As an example, a participant might have a mildly elevated Creatinine Kinase as a result of recent cocaine use. The test would reflect an acute rhabdomyolysis due to recent cocaine use, and it would be clinically significant. Nevertheless, if it is a mild episode as expected with cocaine use, it would not affect brain functioning or increase the risk of the procedures for the participants in the study. Therefore, not all abnormal laboratory findings that have clinical significance will be excluded. If a finding reflects altered brain function (e.g., arrhythmias or renal failure) it will be exclusionary for the study.
✕. Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits as determined by medical history and physical exam.
✕. Head trauma with loss of consciousness for more than 30 minutes as determined by medical history and physical exam.
✕. Pregnant or breast feeding: Females must have negative urine pregnancy test and are not currently breastfeeding. Post-menopausal or surgically sterile (tubal ligation or hysterectomy); or not sexually active with a male partner and able to get pregnant; or documented agreement to use an effective form of birth control. Acceptable forms of contraception include: hormonal contraceptives (birth-control pills, injectable hormones, vaginal-ring hormones); IUD; diaphragm with spermicide; condom with spermicide.